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In the News: October Regulatory and Development Updates

Camargo

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations).

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Pioneering access to complex generic products 

Drug Discovery World

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. There is significant need for more cost-effective generic versions.